Safety and Efficacy of LibiGel® for the Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women (W008)

Trial name: TESTW008 – “A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Safety and Efficacy of LibiGel® for the Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women”

Trial sponsors: BioSante Pharmaceuticals, Inc.

Study start date: March 2008

Estimated study completion date: June 2009

Trial purpose and overview: This study is a randomized, double-blind, placebo-controlled, multi-center study of the safety and efficacy of LibiGel® in the treatment of HSDD in surgically menopausal women taking a stable dose of estrogen therapy.

Study locations and contact:

Contact
Name: Michael Elisseou, Ph.D.
Email: melisseou@biosantepharma.com
Phone number: 847-478-0500 Ext. 102

Locations
United States, Alabama
Recruiting
Mobile, Alabama, United States

United States, Arizona
Recruiting
Phoenix, Arizona, United States
Recruiting
Scottsdale, Arizona, United States
Recruiting
Tucson, Arizona, United States
Recruiting
Glendale, Arizona, United States

United States, Arkansas
Recruiting
Jonesboro, Arkansas, United States
Recruiting
Little Rock, Arkansas, United States

United States, California
Recruiting
Walnut Creek, California, United States
Recruiting
Carmichael, California, United States

United States, Connecticut
Recruiting
New London, Connecticut, United States
Recruiting
Hartford, Connecticut, United States
Recruiting
New Britain, Connecticut, United States

United States, Florida
Recruiting
Orlando, Florida, United States
Recruiting
Crystal River, Florida, United States
Recruiting
Jacksonville, Florida, United States
Recruiting
Aventura, Florida, United States
Recruiting
Ocala, Florida, United States
Recruiting
Tampa, Florida, United States

United States, Georgia
Recruiting
Atlanta, Georgia, United States
Recruiting
Roswell, Georgia, United States

United States, Illinois
Recruiting
Champaign, Illinois, United States
Recruiting
Chicago, Illinois, United States

United States, Indiana
Recruiting
Newburgh, Indiana, United States

United States, Kansas
Recruiting
Overland Park, Kansas, United States

United States, Louisiana
Recruiting
Metarie, Louisiana, United States

Recruiting
Mandeville, Louisiana, United States

United States, Michigan
Recruiting
Paw Paw, Michigan, United States
Recruiting
Bingham Falls, Michigan, United States

United States, Missouri
Recruiting
St. Louis, Missouri, United States

United States, Montana
Recruiting
Billings, Montana, United States

United States, Nevada
Recruiting
Las Vegas, Nevada, United States

United States, New Jersey
Recruiting
Lawrenceville, New Jersey, United States

United States, New York
Recruiting
Purchase, New York, United States
Recruiting
Brooklyn, New York, United States

United States, North Carolina
Recruiting
Raleigh, North Carolina, United States
Recruiting
Winston Salem, North Carolina, United States

United States, Ohio
Recruiting
Beachwood, Ohio, United States
Recruiting
Englewood, Ohio, United States
Recruiting
Cleveland, Ohio, United States
Recruiting
Kettering, Ohio, United States
Recruiting
Gallipolis, Ohio, United States
Recruiting
Mayfield Heights, Ohio, United States
Recruiting
West Chester, Ohio, United States

United States, Oklahoma
Recruiting
Tulsa, Oklahoma, United States

United States, Oregon
Recruiting
Eugene, Oregon, United States
Recruiting
Medford, Oregon, United States

United States, Pennsylvania
Recruiting
Pittsburgh, Pennsylvania, United States
Recruiting
Jenkintown, Pennsylvania, United States

United States, South Carolina
Recruiting
Anderson, South Carolina, United States

United States, Tennessee
Recruiting
North Jackson, Tennessee, United States

United States, Texas
Recruiting
Houston, Texas, United States
Recruiting

Dallas, Texas, United States
Recruiting
Hurst, Texas, United States

United States, Utah
Recruiting
Salt Lake City, Utah, United States
Recruiting
Pleasant Grove, Utah, United States

United States, Washington
Recruiting
Seattle, Washington, United States

United States, Wisconsin
Recruiting
Milwaukee, Wisconsin, United States

Actively recruiting volunteers; Does not enroll healthy volunteers.

Ages eligible for study: 30-65

Inclusion criteria:

must be between the ages of 30 to 65 years

must have undergone hysterectomy and bilateral salpingo-oophorectomy

must be taking a stable dose of estrogen therapy

Exclusion criteria:

a history of allergic reactions to androgens (oral or patch), topical alcohol, or any component of the formulation

any systemic skin diseases or local skin abnormalities in the area of application

diagnosed with another primary female sexual dysfunction (e.g., Sexual Aversion Disorder, Female Sexual Arousal Disorder).

a medical condition that could affect or interfere with sexual function

using a systemic transdermal gel or lotion estrogen therapy.

Other Information Relevant to this Posting

www.bloomstudy.com

posted: August 20, 2008